Continuous insulin therapy to prevent post-transplant diabetes mellitus: A randomized controlled trial

Kurnikowski, Amelie; Werzowa, Johannes M.; Hödlmoser, Sebastian; Krenn, Simon; Paschen, Christopher; Mussnig, Sebastian; Tura, Andrea; Harreiter, Jürgen; Krebs, Michael; Song, Peter X. K.; Eller, Kathrin; Pascual Santos, Julio; Budde, Klemens; Hecking, Manfred; Schwaiger, Elisabeth

Continuous insulin therapy to prevent post-transplant diabetes mellitus: A randomized controlled trial

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dc.contributor.author Kurnikowski, Amelie
dc.contributor.author Werzowa, Johannes M.
dc.contributor.author Hödlmoser, Sebastian
dc.contributor.author Krenn, Simon
dc.contributor.author Paschen, Christopher
dc.contributor.author Mussnig, Sebastian
dc.contributor.author Tura, Andrea
dc.contributor.author Harreiter, Jürgen
dc.contributor.author Krebs, Michael
dc.contributor.author Song, Peter X. K.
dc.contributor.author Eller, Kathrin
dc.contributor.author Pascual Santos, Julio
dc.contributor.author Budde, Klemens
dc.contributor.author Hecking, Manfred
dc.contributor.author Schwaiger, Elisabeth
dc.date.accessioned 2025-07-02T06:27:08Z
dc.date.available 2025-07-02T06:27:08Z
dc.date.issued 2024
dc.description.abstract Rationale & objectives: Hyperglycemia is frequently observed early after transplantation and associated with development of post-transplant diabetes mellitus (PTDM). Here, we assessed continuous subcutaneous insulin infusion (CSII) targeting afternoon hyperglycemia. Study design: Open-label randomized parallel 3-arm design. Settings & participants: In total, 85 kidney transplant recipients without previous diabetes diagnosis were randomized to postoperative CSII therapy, basal insulin, or control. Interventions: Insulin was to be initiated at afternoon capillary blood glucose level of ≥140 mg/dL (7.8 mmol/L; CSII and basal insulin) or fasting plasma glucose level of ≥200 mg/dL (11.1 mmol/L; control). Outcomes: Hemoglobin A1c (HbA1c) levels at 3 months post-transplant (primary endpoint). PTDM assessed using oral glucose tolerance test at 12 and 24 months. Results: CSII therapy lasted until median day 18 and maximum day 88. The median HbA1c value at month 3 was 5.6% (38 mmol/mol) in the CSII group versus 5.7% (39 mmol/mol) in the control group (P = 0.70) and 5.4% (36 mmol/mol) in the basal insulin group (P = 0.02). At months 12 and 24, the odds for PTDM were similar compared with the control group (odds ratios [95% confidence intervals], 0.80 [0.18-3.49] and 0.71 [0.15-3.16], respectively) and the basal insulin group (0.96 [0.18-5.68] and 1.51 [0.24-12.84], respectively). Mild hypoglycemia events occurred in the CSII and the basal insulin groups. Limitations: This study is limited by outdated insulin pump technology, frequent discontinuations of CSII, a complex protocol, and concerns regarding reliability of HbA1c measurements. Conclusions: CSII therapy was not superior at reducing HbA1c levels at month 3 or PTDM prevalence at months 12 and 24 compared with the control or basal insulin group.
dc.format.mimetype application/pdf
dc.identifier.citation Kurnikowski A, Werzowa J, Hödlmoser S, Krenn S, Paschen C, Mussnig S, et al. Continuous insulin therapy to prevent post-transplant diabetes mellitus: A randomized controlled trial. Kidney Med. 2024 Jun 21;6(8):100860. DOI: 10.1016/j.xkme.2024.100860
dc.identifier.doi http://dx.doi.org/10.1016/j.xkme.2024.100860
dc.identifier.issn 2590-0595
dc.identifier.uri http://hdl.handle.net/10230/70814
dc.language.iso eng
dc.publisher Elsevier
dc.relation.ispartof Kidney Med. 2024 Jun 21;6(8):100860
dc.rights © 2024 The Authors. Published by Elsevier Inc. on behalf of the National Kidney Foundation, Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
dc.rights.accessRights info:eu-repo/semantics/openAccess
dc.rights.uri http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subject.keyword American Diabetes Association
dc.subject.keyword Basal insulin
dc.subject.keyword Capillary blood glucose
dc.subject.keyword Continuous glucose monitoring
dc.subject.keyword Continuous subcutaneous insulin infusion
dc.subject.keyword Intention-to-treat
dc.subject.keyword Kidney transplant recipients
dc.subject.keyword Oral glucose tolerance test
dc.subject.keyword Per-protocol
dc.subject.keyword Post-transplant diabetes mellitus
dc.subject.keyword Two-hour plasma glucose
dc.title Continuous insulin therapy to prevent post-transplant diabetes mellitus: A randomized controlled trial
dc.type info:eu-repo/semantics/article
dc.type.version info:eu-repo/semantics/publishedVersion

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